SPEARMINT WHITENING WITH HEMP OIL- sodium monofluorophosphate paste, dentifrice

Spearmint Whitening with Hemp Oil by

Drug Labeling and Warnings

Spearmint Whitening with Hemp Oil by is a Otc medication manufactured, distributed, or labeled by Whole Foods, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion) ...... Anticavity

PURPOSE

Use aids in the prevention of dental cavities

WARNINGS

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor. * Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). * Supervise children as necessary until capable of using without supervision. * Children under 2 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT

Inactive Ingredients glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, cannabis sativa (hemp) seed oil, sodium auroyl sarcosinate, natural flavor, zinc citrate, benzyl alcohol

PRINCIPAL DISPLAY PANEL

Spearmint with Fluoride

Toothpaste

with Hemp Seed Oil

Cavity Fighting & Whitening Net wt 5.5 oz (156g)

INGREDIENTS AND APPEARANCE

SPEARMINT WHITENING WITH HEMP OIL 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42681-0019
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARRAGEENAN (UNII: 5C69YCD2YJ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ZINC CITRATE (UNII: K72I3DEX9B)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
XYLITOL (UNII: VCQ006KQ1E)
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42681-0019-1	156 g in 1 TUBE; Type 0: Not a Combination Product	04/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/29/2020

Labeler - Whole Foods (196175616)

Registrant - Lornamead (080046441)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(42681-0019)